When procedures are performed on a patient in a catheterization lab, an electrophysiology laboratory, or an interventional radiology or operative suite, a number of longitudinally extending, or elongated, medical devices or members are employed. Dependent upon which procedure is being performed, any number of catheters, guide wires, guiding catheters, sheaths, leads, or other elongated medical devices or members can be used. These elongated medical devices or members are primarily very long thin tubes or rods that may come in a variety of lengths and widths. The operator has the responsibility to carefully manipulate these elongated medical devices or members in sometimes very complex proceedings.
In some of the procedures it is necessary to insert one elongated medical device or member into a patient and then to keep that elongated medical device or member in position while an operator inserts or retracts another elongated medical device or member. As a result, there can be a number of coextensively extending elongated medical devices or members where the relative positions have to be maintained. At the present time, it is part of the operator's technique to maintain the respective elongated medical devices or members in desired relationships to one another.
The management of coextensively extending elongated medical devices or members is a concern during, for example, an electrophysiology study or a catheter ablation procedure. Typically a number of catheters are placed through either veins or arteries into a variety of locations within the heart. These catheters can, for example, record specific potentials, and they often move out of place. This movement is due to the fact that standard introducer sheaths only provide a small amount of resistance and patient and/or catheter movement during the procedure can easily dislodge a catheter tip's position. Also, a patient may move his or her body or legs when shocked or due to discomfort. Sometimes a more bulky and expensive “lock-down” sheath can be used to prevent catheter movement; however, this is impractical for use in procedures that require multiple catheters. Having to reposition catheters or wires adds time to a procedure and increases radiation exposure.
At times an operator must deliver and keep a flexible elongated medical device or member in a fixed position either through a single vessel or through vessels which terminate in a single vascular structure. In one circumstance, the operator passes two or more pairs of flexible elongated medical devices or members through the same blood vessel, either directly via a cut-down procedure, though as single introducer, or through a Y-adaptor. The multiple flexible elongated medical devices or members travel down a single or multiple veins and/or arteries such that the elongated medical devices or members are positioned in the heart and circulatory either for diagnostic and/or therapeutic purposes. Their apposition, next to each other, may hinder the stable position of one member, while the other is positioned.
The multiple elongated medical devices or members may be, for example, guide wires, catheters, pacemaker leads, or sheaths. Since the elongated medical devices or members may have similar points of entry such as the right groin for the right femoral artery and vein, the operator must take steps to keep the elongated medical devices or members organized and separate from each other, and to keep each member identified with the location and purpose. It is important to keep the elongated medical devices or members separate for several reasons. If the elongated medical devices or members become twisted, they will interact with one another. For instance, when the operator moves one wire or catheter, another wire or catheter may also move out of position. Further, different devices, such as stents, are typically passed over the guide wires on the catheters; therefore, if the wire/catheter pairs become twisted with each other, accurate advancement of the associated devices is hindered. Also, since different devices are passed over the different wires on the catheters, the operator must take steps to identify each wire so as not to confuse which wire is going down which vessel or branch vessel.
During electrophysiology procedures and/or cardiac catheter ablation procedures multiple catheters are positioned in a single blood vessel such as the right femoral vein and perhaps the right femoral artery, all in proximity to one another. The wires are often placed in very discrete locations to record and diagnose a particular condition. It is not infrequent for four such catheters to be located in one groin location. Movement of the patient could result in catheter movement and require repositioning. Lock-down introducers are useful, but expensive. There is a need for a simple and inexpensive catheter management system to hold catheters of a variety of shapes in place and for such a system to be able to rapidly and quickly release the catheter(s) for further mapping and repositioning.
Another comparable example of the same effect as described above is implantation of a multi-lead implantable heart rhythm device such as a pacemaker or defibrillator (and a biventricular device typically has three leads). Very frequently, those leads are implanted through a single blood vessel such as the cephalic, auxillary, or subclavian vein. To prevent the problem of unintended movement, the operator may have to percutaneously stick a second blood vessel, thereby subjecting the patient to additional vascular or pneumothorax risk. In addition, placement of “a third lead” such as the left ventricular lead used in biventricular devices, eventually requires a process of slitting a long sheath, which often may dislodge previously placed leads in more traditional locations such as the right atrium and ventricle. This typically lengthens and complicates these procedures. A method of easily securing leads while positioning another is needed. In addition, a method of securing leads while slitting a deliverable lead is also required. Further, a method of easily releasing the leads for additional positioning is required.